Ensuring safe and effective products through well-defined drug substances and test methods
To appropriately manufacture a pharmaceutical or biological product, a well-defined drug substance and product, manufacturing process and test methods must be developed in order to ensure that the product is safe, effective and consistent between batches. This is a prerequisite to get regulatory approval to study
an investigational medicinal product on humans. Collectively, these activities are known as CMC, chemistry, manufacturing and control. CMC plays a crucial role in all stages of the product life cycle including early and late phases of development and even after marketing authorization when the product is on the market. CMC covers a wide range of activities including product, process and test method development, product stability testing, phase appropriate validation, and manufacturing and testing under GMP conditions.